Kornimate/medical-research-clean huggingface dataset:
rehabilitation robot in patients with post-coronavirus disease (covid-19) fatigue syndrome

Conditions: Post-Viral Fatigue Syndrome

Summary: the aim of the study is to compare the effectiveness of two models of rehabilitation: * traditional neurological rehabilitation, and * neurological rehabilitation combined with a rehabilitation robot (luna by egzotech). an additional goal is to test the qualitative diagnostic reference using the surface electromyogram of the luna robot (certified as a medical device) for functional diagnostics based on standardized clinical tests.


Eligibility criteria:
inclusion criteria: - patients discharged from intensive care units after undergone ventilator therapy due to covid-19 exclusion criteria: * active medical condition (infections; tumors; rheumatological, metabolic, endocrine, autoimmunological, cardiovascular diseases) * bipolar disorder * dementia * nutritional disorders * addiction to alcohol or psychoactive substances * severe obesity * overtraining
a prospective clinical study to assess the clinical utility of turbidity in patients using in-home peritoneal dialysis

Conditions: End Stage Renal Disease; Peritoneal Dialysis-associated Peritonitis; Peritonitis

Summary: this study aims to determine if the cloudcath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.

this study will evaluate the safety and effectiveness of the cloudcath system to detect the onset of peritonitis as compared to standard of care. study participants will connect the cloudcath system to their home peritoneal dialysis unit and the cloudcath system will analyze the effluent dialysis solution for changes associated with peritonitis. the system will alert the participant and healthcare provider if it detects a possible infection so they can be formally diagnosed by their healthcare provider. following enrollment, study participants will use the cloudcath system for 12 continuous months. study results from the act study will be compared to the results of the catch study (protocol number cc-p-001; nct04515498). in catch, the study participants used a cloudcath system; however, the notification capabilities (per the cloudcath system algorithm) were deactivated.

Eligibility criteria:
key inclusion criteria: * currently using peritoneal dialysis * provides informed consent * willing to comply with the requirements of the study * has cellular data coverage at home key exclusion criteria: * active or history of cancer requiring chemotherapy within prior 6 months * signs or symptoms of an active infection within 14 days prior to enrollment * peritonitis diagnosis within 30 days prior to enrollment * participating in another investigational device or drug study that may potentially affect study results * other medical, social or psychological problems that, in the opinion of the investigator, exclude the study participant from the study
iressa and radiotherapy in the treatment of the locally advanced inoperable squamous cell carcinoma of the head and neck

Conditions: Head and Neck Cancer; Carcinoma, Squamous Cell

Summary: the aim of the study is to determine if iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.


Eligibility criteria:
inclusion criteria: * histologically confirmed locally advanced squamous cell carcinoma of head and neck * at least one measurable tumour lesion exclusion criteria: * no previous treatment such as chemotherapy, radiotherapy and/or surgery for carcinoma head and neck * no other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Keywords: squamous cell carcinoma of head and neck inoperable locally advanced squamous cell carcinoma of head and neck
microfluo: fluorescence-guided surgery for ovarian cancer

Conditions: Ovarian Cancer

Summary: epithelial ovarian cancers (eoc) are discovered in 75% of cases at an advanced stage, marked by the presence of peritoneal carcinomatosis. it has been shown that one of the main prognostic factors is the achievement of a macroscopically complete cytoreductive surgery, i.e. without visible peritoneal metastasis at the end of the procedure. the prognosis of patients is inversely correlated to the tumor residue at the end of the procedure, and 60% of patients present a peritoneal recurrence within two years after the initial management. this suggests that microscopic peritoneal metastases may be present that are not eradicated by surgery and not controlled by systemic chemotherapy. their presence could be involved in the mechanisms leading to the occurrence of peritoneal recurrence. the micropci protocol (nct03754569), showed that microscopic peritoneal metastases were present at the end of macroscopically complete surgery of advanced-stage eoc in 98.14% of cases.this naturally lead to the question of the impact of microscopic cytoreduction on the prognosis of patients. fluorescence detection of peritoneal metastases after intravenous injection of indocyanine green (icg) and their resection have already been evaluated with promising results in digestive and ovarian carcinomas. the objective of the microfluo protocol is to propose on the one hand a diagnostic time by fluorescence during the laparoscopic evaluation performed to define the resectability of the peritoneal carcinomatosis and also at the end of the macroscopically complete cytoreductive surgery to perform the biopsy of the fluorescent areas suspected of presenting residual microscopic peritoneal metastases. patients diagnosed with peritoneal carcinomatosis undergo exploratory laparoscopy, during which lesion mapping is performed to assess the resectability of the lesions. a biopsy is performed during this procedure to confirm the histological diagnosis. an initial fluorescence mapping will be performed at this diagnostic time. once cytoreductive surgery has been performed, intravenous injection of icg is performed according to the manufacturer's recommendations. peritoneal lesions emitting a fluorescent signal will be sampled. these samples will be studied in anatomopathology under the same conditions as the other surgical parts. no increase in morbidity is expected in relation to this study. the number of specimens taken is dependent on the peritoneal tumor burden.


Eligibility criteria:
inclusion criteria: * patient at least 18 years of age. * presenting with an epithelial ovarian cancer * affiliated to a social security system * having received full information on the organization of the research and having given written consent. exclusion criteria: * borderline ovarian tumor. * non french speaking patient. * patient under a legal protection measure (guardianship, curatorship, safeguard of justice).

Keywords: ovarian cancer fluorescence guided surgery indocyanine green cytoreductive surgery peritoneal carcinomatosis
luminous efficiency function v(λ)' of patients that underwent pseudophakic presbyopic corrections

Conditions: Presbyopia

Summary: primary objective of this study is to construct and validate a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients that underwent bilateral pseudophakic presbyopic correction with trifocal intraocular lenses (iols) implantations.

present study aims to identify in which degree multifocal iols modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following bilateral pseudophakic presbyopic corrections. specifically, the aim of this study is to identify the minimum light intensity in which patients that underwent pseudophakic presbyopic correction with trifocal iols can reach their maximum visual acuity (measured when lights are at the 100% lighting level)

Eligibility criteria:
inclusion criteria: * age between 45 to 70 years exclusion criteria: * astigmatism \>1.00 diopters * glaucoma * former incisional eye surgery * corneal or fundus disease * diabetes mellitus * autoimmune diseases * neurological or psychiatric diseases * posterior capsule rupture or lens misalignment * postoperative uncorrected bilateral distant visual acuity \< 8/10.

Keywords: pseudophakic presbyopic correction trifocal intraocular lens light intensity eye light transmittance light efficiency function
a double-blind, randomized, placebo-controlled study of the efficacy and safety of weekly procrit given to gastric or rectal patients

Conditions: Gastrointestinal Cancer; Rectal Cancer

Summary: to demonstrate the effectiveness of epoetin alfa on reduction in red blood cell transfusions in gastric and rectal cancer patients undergoing preoperative chemoradiation therapy followed by surgery.

anemia and fatigue are common problems in gastric and rectal cancer subjects at the completion of chemoradiation therapy and surgery. results of several studies in cancer subjects suggest that treatment with epoetin alfa may be effective in maintaining hemoglobin levels, thereby reducing fatigue, decreasing transfusion requirement, and potentially improving quality of life.

Eligibility criteria:
inclusion criteria: * male or female 18 years of age or older * must have a confirmed diagnosis of gastric or rectal cancer for whom the treatment plan is preoperative chemoradiation followed by surgery * must have a baseline hemoglobin \>/= 10 g/dl and \< 15 g/dl * must have adequate hematologic function * must have life expectancy of more than 6 months * karnofsky performance status of at least 50% * must have adequate renal function * patients with reproductive potential must use an adequate contraceptive method during treatment and three months after completing treatment * patients must be able to read, understand, and complete the three quality of life questionnaires in english. exclusion criteria: * prior chemotherapy for patients with rectal cancer * gastric cancer patients who have received more than 2 cycles of chemotherapy * anemia due to factors other than cancer/chemotherapy * patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous 6 months * known hypersensitivity to mammalian-cell derived products or to human albumin * pregnant or lactating women * untreated central nervous system metastases * any significant, uncontrolled disease/dysfunction of any of the major organs * uncontrolled hypertension or history of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis * new onset or poorly controlled seizures * history of active second malignancy * major infection requiring hospitalization and antibiotics or surgery within 14 days of study entry * blood transfusion within 1 month of study entry * androgen therapy within 2 months of study entry

Keywords: epoetin alfa epogen erythropoietin
a validity and reliability study for urdu version of rivermead mobility index in stroke patients

Conditions: Stroke

Summary: the aim of the study is to translate and cross-culturally adapt the rivermead mobility index questionnaire into traditional urdu language to investigate its psychometric properties (reliability \& validity) for those patients who are confronting stroke.

as per preceding commendation, rivermead mobility index will be translated into urdu language from its english version and adapted culturally in pakistan. among stroke population, rivermead mobility index will be conducted in 50 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. for testing inter-observer reliability and intra-observer reliability of rivermead mobility index, barthel index and functional independence measure will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. as for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. statistical package of social sciences software version 24 has been used for the purpose of data entry and analysis. internal consistency will be assessed by using an intra-class correlation coefficient. the rivermead mobility index will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility criteria:
inclusion criteria: * male and female both genders * adults between the ages of 18 and above * stroke patients ( chronic) * ability to provide informed consent exclusion criteria: * any musculoskeletal pathologies * suffering from any cardiovascular pathologies * any history of fracture * any histories of infections * any history of neurological disorders * having any spinal deformity

Keywords: rivermead mobility index urdu version reliability validity stroke mobility
postpartum diabetes screening in women with gestational diabetes

Conditions: Diabetes, Gestational

Summary: assess postpartum diabetes screening in gdm patients with initiation of a reminder system in the postpartum period


Eligibility criteria:
inclusion criteria: gdm, english speaking - exclusion criteria: non english speaking. younger than 18 years of age -
marimpach : contribution of high-resolution manometry with impedancemetry for the evaluation of esophageal clearance in achalasia

Conditions: Esophageal Achalasia

Summary: outcome after treatment of achalasia is usually assessed by the eckardt score (es). the timed barium esophagogram (tbe) is used to objectively assess esophageal clearance after treatment. high-resolution manometry with impedancemetry (hrim) provides information on esophageal clearance of liquids in addition to motility parameters. the aim of this study was to compare esophageal clearance determined by hrim and tbe in patients with achalasia treated by poem.

consecutive patients treated with poem had pre and post-poem assessment with es, tbe, and hrim. treatment failure was defined by an es \> 3 at 3 months post-poem. incomplete esophageal clearance (iec) was defined by the presence of an esophageal stasis \> 2 cm at 5 minutes in hrim and/or tbe. the eckardt score is evaluated at one year to estimate the prognostic value of measurements of esophageal clearance after treatment on long-term symptoms. the evaluation of the eckardt score will be compared to the quality of life score. all of these examinations are carried out as part of routine care. the supposed superiority of hrim in the evaluation of esophageal clearance, systematically carried out in the assessment of achalasia, could lead to no longer using tbe which is a irradiating examination for the patient.

Eligibility criteria:
inclusion criteria: * the patients included are all patients treated by poem at bordeaux university hospital between october 2020 and september 2024. exclusion criteria: * primary poem failure, lost to follow-up, absence of completion of the es, tbe or hrim pre or post poem at 3 months.

Keywords: timed baryum esophagogram high-resolution manometry with impedancemetry esophageal clearance eckardt score
a phase 2 study to evaluate the safety and tolerability of pbi-4050 in patients with idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Summary: this is a phase 2, open-label, single-arm study of the safety and tolerability of pbi-4050 800 mg daily oral administration in 40 adult patients with ipf.

this phase 2 multi-centre study will be performed by 6 canadian sites. it is an open-label, single-arm study in patients with idiopathic pulmonary fibrosis (ipf) aged 40 years and older. the duration of study participation is approximately 20 weeks for each patient and comprises 6 study visits.

Eligibility criteria:
inclusion criteria: 1. patient is an adult aged 40 years or older 2. patient has signed written informed consent. 3. patient has been diagnosed of ipf according to the most recent guideline on ipf diagnosis and management released by american thoracic society (ats), european respiratory society (ers), japanese respiratory society (jrs), and latin american thoracic association (alat). 4. female patients of childbearing potential must have a negative urine pregnancy test and agree to use adequate birth control from screening throughout the study and for 30 days after the last study drug administration. 5. if a male patient has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the last study drug administration. exclusion criteria: 1. patient has a known diagnosis of a respiratory disorder other than ipf. 2. substantial emphysema on high resolution computer tomography (hrct) with degree of emphysema greater than fibrosis. 3. patient is an active smoker. 4. patient has evidence of active infection. 5. patients currently has or has a history of cancer, except basal cell carcinoma or squamous cell carcinoma of the skin. 6. patient has a concurrent medical or psychological condition that, in the investigator's opinion, may compromise the patient's ability to participate in the study or give informed consent, or may complicate the evaluations of the study drug. 7. patient is receiving another investigational treatment for ipf at screening and/or plans to receive an investigational treatment for ipf during the current study. 8. patient has chronic hepatitis or significantly elevated liver enzyme levels, defined as alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥ 2.5 × upper limit of normal (uln) or total bilirubin above uln. 9. female patient who is pregnant, breast-feeding, or planning a pregnancy during the course of the study. 10. woman of childbearing potential who is unwilling to use adequate birth control throughout the duration of the study. 11. patient has participated in an investigational clinical trial during the last 4 weeks.
application of rapid on-site evaluation in lymph node biopsy of breast cancer

Conditions: Breast Cancer

Summary: the goal of this clinical trial is to evaluate the value of rapid on-site evaluation（rose） in lymph node biopsy of breast cancer. the main question it aims to answer is:the rose technique was applied to breast cancer lymph node biopsy to improve the diagnostic efficiency and accuracy. participants underwent routine lymph node biopsy, and the test personnel conducted routine disease examination and rose technique evaluation on the removed ly


Eligibility criteria:
inclusion criteria: * patients had pathologically confirmed primary breast cancer * surgical treatment was available exclusion criteria: * previous history of surgery on the affected axilla, internal breast or chest * pregnant or breastfeeding patients * previous radiotherapy or chemotherapy * complicated history of other tumors
sf2a-tt15 conjugate vaccine in healthy adult volunteers

Conditions: Shigellosis; Bacillary Dysentery

Summary: this is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.

subjects will be assigned to one of two cohorts. 1. cohort 1 will receive the lower dose of 2 μg vaccine (with or without alum adjuvant) or matching placebo. 2. cohort 2 will receive the higher dose of 10 μg vaccine (with or without alum adjuvant) or matching placebo. eligible subjects will be randomized to receive the 2 μg dose or 10 µg without or with alum or matching placebo, at a ratio of 3:1, as three single im injections. there will be an interval of 28(±3) days) between each treatment. the study will be conducted in a stepwise approach in which a "pioneer" group of 2 subjects (one receiving the active vaccine and one receiving the matching placebo) will receive the first injection. these subjects will remain in-house for a 24-hours medical observation after the first injection (not required in the subsequent injections) once it has been established that there are no safety concerns in the non-adjuvanted "pioneer" groups (and after no less than 48 hrs), the next "pioneer" group (one subject receiving adjuvanted 2 μg vaccine and one receiving the matching alum placebo) will be injected. if no safety concerns are raised in this group also, after no less than 48 hrs, the rest of the subjects may receive the first injection.

Eligibility criteria:
inclusion criteria * subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination. * negative human leukocyte antigen (hla) -b27 and no history of reactive arthritis * negative hiv, hepatitis b and hepatitis c serology tests. * blood levels of shigella flexneri 2a lps igg antibodies ≤ percentile 80 * no known history of alcohol abuse exclusion criteria * subjects with a history of clinically significant gastrointestinal disorders or with any history of frequent diarrhea, nausea or emesis, regardless of etiology. * individuals with immunosuppressive diseases or under immunosuppressive therapy * history of culture-proven s. flexneri. * individuals who have household contact with/and /or intimate exposure to an individual with laboratory confirmed s. flexneri. * having travelled in countries/areas highly endemic for s. flexneri within 3 months prior to enrolment. * previous participation in any study in which a shigella-vaccine candidate was administered. * known contraindication, hypersensitivity and/or allergy to the investigational product or its excipients. * known hypersensitivity and/or allergy to any drug or vaccine * women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study.

Keywords: phase i conjugate vaccine shigella flexneri 2a safety immunogenicity healthy adults